Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
Reported: October 28, 2020 Initiated: September 11, 2020 #Z-0178-2021
Product Description
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
Reason for Recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Details
- Recalling Firm
- Bien-Air Surgery Sa
- Units Affected
- Total US = 1120 foot pedals
- Distribution
- US Nationwide distribution including in the states of CA, MI and MN.
- Location
- Le Noirmont, N/A
Frequently Asked Questions
What product was recalled? ▼
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.. Recalled by Bien-Air Surgery Sa. Units affected: Total US = 1120 foot pedals.
Why was this product recalled? ▼
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0178-2021.
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